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A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

Last updated on December 5, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diarrhoea
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteers 18-70 years of age

- Subjects with normal gastrointestinal function

- Subjects willing to provide written informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects receiving antibiotic treatment within three months prior to inclusion in the
study

- Pregnancy or planned pregnancy

- Breast feeding

- Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or
its components

- Subjects with known renal insufficiency

- Subjects using products containing probiotics, fibers and/or prebiotics

- Subjects using proton pump inhibitors

- Subjects using H2 antagonists

- Subjects using antacids frequently

NCT01491659
Pfizer
Withdrawn
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Brief SummaryIt is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Diarrhoea
Intervention  ICMJE
  • Dietary Supplement: Idoform Plus
    orally once daily
  • Dietary Supplement: Placebo
    orally once daily
Study Arms  ICMJE
  • Active Comparator: Amoxicillin/clavulanate/Idoform Plus
    Intervention: Dietary Supplement: Idoform Plus
  • Placebo Comparator: Amoxicillin/clavulanate/Placebo
    Intervention: Dietary Supplement: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 23, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2011)
170
Estimated Study Completion Date  ICMJE March 2013
Estimated Primary Completion DateMarch 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers 18-70 years of age
  • Subjects with normal gastrointestinal function
  • Subjects willing to provide written informed consent

Exclusion Criteria:

  • Subjects receiving antibiotic treatment within three months prior to inclusion in the study
  • Pregnancy or planned pregnancy
  • Breast feeding
  • Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components
  • Subjects with known renal insufficiency
  • Subjects using products containing probiotics, fibers and/or prebiotics
  • Subjects using proton pump inhibitors
  • Subjects using H2 antagonists
  • Subjects using antacids frequently
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location CountriesDenmark
 
Administrative Information
NCT Number  ICMJE NCT01491659
Other Study ID Numbers  ICMJE B4141002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Danisco/Dupont
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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